HonorHealth Research Institute offers first-of-its-kind Type 2 diabetes clinical trial for children ages 10-17

Once-a-week injection would replace need for daily injections or daily oral medications, resulting in more-stable blood-sugar levels

SCOTTSDALE, Ariz. — Sept. 26, 2024 — A first-of-its-kind clinical trial is being offered by HonorHealth Research Institute for children and teenagers — ages 10-17 — with Type 2 diabetes that may enable them to control their disease with just one injection a week.

A medication, LY3209590, would strive to keep these children’s blood-sugar levels more stable, avoiding the fluctuating blood-sugar levels that can result with daily injections of currently FDA approved Type 2 diabetes medications.

By switching from a daily injection to a weekly shot, there may also be an opportunity to reduce the children’s pain and bruising as well as the number of infections that can result from daily shots. Plus, a general reduction in the hassle that goes along with the storing, prepping and administering of daily insulin shots versus a single weekly injection.

“This will provide a more controlled release of medication over a week’s time to keep the release steady without the use of an insulin pump. Instead of doing it seven times a week, you do it once a week,” said James Swain, M.D., medical director of the Research Institute’s GI/Bariatrics Research Division and the principal investigator of the I8H-MC-BDDB study, sponsored by Cambridge Mass.-based Eli Lilly, and Company.

“This will be the first study to evaluate LY3209590 in pediatric patients with Type 2 diabetes,” said Dr. Swain, adding that a once-a-week insulin such as LY3209590 may help to overcome commonly observed difficulties in initiating and adhering to insulin therapy. LY3200590 has been successfully tested in three studies of diabetic adults, resulting in excellent glycemic control, according to Dr. Swain.

Both the children and their parents would be compensated for their participation in the trial.

Other participant qualifications

In addition to the age restrictions (ages 10-17), participants must have HbA1c levels (a long-term indicator of blood sugar levels) of between 6.5% and 9.5% and not have taken insulin within the past 3 months.

Qualifying participants will receive a single injection of LY3209590, followed by blood tests and other procedures at subsequent clinical visits, some in-home visits, plus a follow-up phone call. The study drug and any tests that are required as part of the study will be provided at no cost.

Type 2 diabetes in children is a chronic disease that affects the way the body processes sugar. Without treatment, the disorder causes sugar to build up in the bloodstream, which can lead to serious long-term health consequences.

The condition has multiple causes, said Dr. Swain, including genetic predispositions, excess weight and insulin resistance: “They may be naturally producing insulin but they’re not sensitive to it, so they need more insulin to drive the sugars down.”

For more information about HonorHealth Research Institute clinical trials, call 480-323-1292.